Can we Save the rectum by watchful waiting or TransAnal microsurgery following (chemo) Radiotherapy versus Total mesorectal excision for early REctal Cancer (STAR-TREC study)?: protocol for a multicentre, randomised feasibility study

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Can we Save the rectum by watchful waiting or TransAnal microsurgery following (chemo) Radiotherapy versus Total mesorectal excision for early REctal Cancer (STAR-TREC study)?: protocol for a multicentre, randomised feasibility study. / Rombouts, Anouk J M; Al-Najami, Issam; Abbott, Natalie L; Appelt, Ane; Baatrup, Gunnar; Bach, Simon; Bhangu, Aneel; Garm Spindler, Karen-Lise; Gray, Richard; Handley, Kelly; Kaur, Manjinder; Kerkhof, Ellen; Kronborg, Camilla Jensenius; Magill, Laura; Marijnen, Corrie A M; Nagtegaal, Iris D; Nyvang, Lars; Peters, Femke P; Pfeiffer, Per; Punt, Cornelis; Quirke, Philip; Sebag-Montefiore, David; Teo, Mark; West, Nick; de Wilt, Johannes H W; for STAR-TREC Collaborative Group.

I: BMJ Open, Bind 7, Nr. 12, 28.12.2017, s. e019474.

Publikation: Bidrag til tidsskrift/Konferencebidrag i tidsskrift /Bidrag til avisTidsskriftartikelForskningpeer review

Harvard

Rombouts, AJM, Al-Najami, I, Abbott, NL, Appelt, A, Baatrup, G, Bach, S, Bhangu, A, Garm Spindler, K-L, Gray, R, Handley, K, Kaur, M, Kerkhof, E, Kronborg, CJ, Magill, L, Marijnen, CAM, Nagtegaal, ID, Nyvang, L, Peters, FP, Pfeiffer, P, Punt, C, Quirke, P, Sebag-Montefiore, D, Teo, M, West, N, de Wilt, JHW & for STAR-TREC Collaborative Group 2017, 'Can we Save the rectum by watchful waiting or TransAnal microsurgery following (chemo) Radiotherapy versus Total mesorectal excision for early REctal Cancer (STAR-TREC study)?: protocol for a multicentre, randomised feasibility study', BMJ Open, bind 7, nr. 12, s. e019474. https://doi.org/10.1136/bmjopen-2017-019474

APA

Rombouts, A. J. M., Al-Najami, I., Abbott, N. L., Appelt, A., Baatrup, G., Bach, S., Bhangu, A., Garm Spindler, K-L., Gray, R., Handley, K., Kaur, M., Kerkhof, E., Kronborg, C. J., Magill, L., Marijnen, C. A. M., Nagtegaal, I. D., Nyvang, L., Peters, F. P., Pfeiffer, P., ... for STAR-TREC Collaborative Group (2017). Can we Save the rectum by watchful waiting or TransAnal microsurgery following (chemo) Radiotherapy versus Total mesorectal excision for early REctal Cancer (STAR-TREC study)?: protocol for a multicentre, randomised feasibility study. BMJ Open, 7(12), e019474. https://doi.org/10.1136/bmjopen-2017-019474

CBE

Rombouts AJM, Al-Najami I, Abbott NL, Appelt A, Baatrup G, Bach S, Bhangu A, Garm Spindler K-L, Gray R, Handley K, Kaur M, Kerkhof E, Kronborg CJ, Magill L, Marijnen CAM, Nagtegaal ID, Nyvang L, Peters FP, Pfeiffer P, Punt C, Quirke P, Sebag-Montefiore D, Teo M, West N, de Wilt JHW, for STAR-TREC Collaborative Group. 2017. Can we Save the rectum by watchful waiting or TransAnal microsurgery following (chemo) Radiotherapy versus Total mesorectal excision for early REctal Cancer (STAR-TREC study)?: protocol for a multicentre, randomised feasibility study. BMJ Open. 7(12):e019474. https://doi.org/10.1136/bmjopen-2017-019474

MLA

Vancouver

Author

Rombouts, Anouk J M ; Al-Najami, Issam ; Abbott, Natalie L ; Appelt, Ane ; Baatrup, Gunnar ; Bach, Simon ; Bhangu, Aneel ; Garm Spindler, Karen-Lise ; Gray, Richard ; Handley, Kelly ; Kaur, Manjinder ; Kerkhof, Ellen ; Kronborg, Camilla Jensenius ; Magill, Laura ; Marijnen, Corrie A M ; Nagtegaal, Iris D ; Nyvang, Lars ; Peters, Femke P ; Pfeiffer, Per ; Punt, Cornelis ; Quirke, Philip ; Sebag-Montefiore, David ; Teo, Mark ; West, Nick ; de Wilt, Johannes H W ; for STAR-TREC Collaborative Group. / Can we Save the rectum by watchful waiting or TransAnal microsurgery following (chemo) Radiotherapy versus Total mesorectal excision for early REctal Cancer (STAR-TREC study)?: protocol for a multicentre, randomised feasibility study. I: BMJ Open. 2017 ; Bind 7, Nr. 12. s. e019474.

Bibtex

@article{7f781b20c7884acd89a2d4d51c392d9a,
title = "Can we Save the rectum by watchful waiting or TransAnal microsurgery following (chemo) Radiotherapy versus Total mesorectal excision for early REctal Cancer (STAR-TREC study)?: protocol for a multicentre, randomised feasibility study",
abstract = "INTRODUCTION: Total mesorectal excision (TME) is the highly effective standard treatment for rectal cancer but is associated with significant morbidity and may be overtreatment for low-risk cancers. This study is designed to determine the feasibility of international recruitment in a study comparing organ-saving approaches versus standard TME surgery.METHODS AND ANALYSIS: STAR-TREC trial is a multicentre international randomised, three-arm parallel, phase II feasibility study in patients with biopsy-proven adenocarcinoma of the rectum. The trial is coordinated from Birmingham, UK with national hubs in Radboudumc (the Netherlands) and Odense University Hospital Svendborg UMC (Denmark). Patients with rectal cancer, staged by CT and MRI as ≤cT3b (up to 5 mm of extramural spread) N0 M0 can be included. Patients will be randomised to either standard TME surgery (control), organ-saving treatment using long-course concurrent chemoradiation or organ-saving treatment using short-course radiotherapy. For patients treated with an organ-saving strategy, clinical response to (chemo)radiotherapy determines the next treatment step. An active surveillance regime will be performed in the case of a complete clinical regression. In the case of incomplete clinical regression, patients will proceed to local excision using an optimised platform such as transanal endoscopic microsurgery or other transanal techniques (eg, transanal endoscopic operation or transanal minimally invasive surgery). The primary endpoint of this phase II study is to demonstrate sufficient international recruitment in order to sustain a phase III study incorporating pelvic failure as the primary endpoint. Success in phase II is defined as randomisation of at least four cases per month internationally in year 1, rising to at least six cases per month internationally during year 2.ETHICS AND DISSEMINATION: The medical ethical committees of all the participating countries have approved the study protocol. Results of the primary and secondary endpoints will be submitted for publication in peer-reviewed journals.TRIAL REGISTRATION NUMBER: ISRCTN14240288, 20 October 2016. NCT02945566; Pre-results, October 2016.",
keywords = "Adenocarcinoma/pathology, Chemoradiotherapy/methods, Digestive System Surgical Procedures/methods, Europe, Feasibility Studies, Humans, Microsurgery/methods, Organ Sparing Treatments, Rectal Neoplasms/pathology, Rectum/pathology, Regression Analysis, Research Design, Treatment Outcome, Watchful Waiting",
author = "Rombouts, {Anouk J M} and Issam Al-Najami and Abbott, {Natalie L} and Ane Appelt and Gunnar Baatrup and Simon Bach and Aneel Bhangu and {Garm Spindler}, Karen-Lise and Richard Gray and Kelly Handley and Manjinder Kaur and Ellen Kerkhof and Kronborg, {Camilla Jensenius} and Laura Magill and Marijnen, {Corrie A M} and Nagtegaal, {Iris D} and Lars Nyvang and Peters, {Femke P} and Per Pfeiffer and Cornelis Punt and Philip Quirke and David Sebag-Montefiore and Mark Teo and Nick West and {de Wilt}, {Johannes H W} and {for STAR-TREC Collaborative Group}",
note = "{\textcopyright} Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.",
year = "2017",
month = dec,
day = "28",
doi = "10.1136/bmjopen-2017-019474",
language = "English",
volume = "7",
pages = "e019474",
journal = "B M J Open",
issn = "2044-6055",
publisher = "BMJ Publishing Group",
number = "12",

}

RIS

TY - JOUR

T1 - Can we Save the rectum by watchful waiting or TransAnal microsurgery following (chemo) Radiotherapy versus Total mesorectal excision for early REctal Cancer (STAR-TREC study)?: protocol for a multicentre, randomised feasibility study

AU - Rombouts, Anouk J M

AU - Al-Najami, Issam

AU - Abbott, Natalie L

AU - Appelt, Ane

AU - Baatrup, Gunnar

AU - Bach, Simon

AU - Bhangu, Aneel

AU - Garm Spindler, Karen-Lise

AU - Gray, Richard

AU - Handley, Kelly

AU - Kaur, Manjinder

AU - Kerkhof, Ellen

AU - Kronborg, Camilla Jensenius

AU - Magill, Laura

AU - Marijnen, Corrie A M

AU - Nagtegaal, Iris D

AU - Nyvang, Lars

AU - Peters, Femke P

AU - Pfeiffer, Per

AU - Punt, Cornelis

AU - Quirke, Philip

AU - Sebag-Montefiore, David

AU - Teo, Mark

AU - West, Nick

AU - de Wilt, Johannes H W

AU - for STAR-TREC Collaborative Group

N1 - © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

PY - 2017/12/28

Y1 - 2017/12/28

N2 - INTRODUCTION: Total mesorectal excision (TME) is the highly effective standard treatment for rectal cancer but is associated with significant morbidity and may be overtreatment for low-risk cancers. This study is designed to determine the feasibility of international recruitment in a study comparing organ-saving approaches versus standard TME surgery.METHODS AND ANALYSIS: STAR-TREC trial is a multicentre international randomised, three-arm parallel, phase II feasibility study in patients with biopsy-proven adenocarcinoma of the rectum. The trial is coordinated from Birmingham, UK with national hubs in Radboudumc (the Netherlands) and Odense University Hospital Svendborg UMC (Denmark). Patients with rectal cancer, staged by CT and MRI as ≤cT3b (up to 5 mm of extramural spread) N0 M0 can be included. Patients will be randomised to either standard TME surgery (control), organ-saving treatment using long-course concurrent chemoradiation or organ-saving treatment using short-course radiotherapy. For patients treated with an organ-saving strategy, clinical response to (chemo)radiotherapy determines the next treatment step. An active surveillance regime will be performed in the case of a complete clinical regression. In the case of incomplete clinical regression, patients will proceed to local excision using an optimised platform such as transanal endoscopic microsurgery or other transanal techniques (eg, transanal endoscopic operation or transanal minimally invasive surgery). The primary endpoint of this phase II study is to demonstrate sufficient international recruitment in order to sustain a phase III study incorporating pelvic failure as the primary endpoint. Success in phase II is defined as randomisation of at least four cases per month internationally in year 1, rising to at least six cases per month internationally during year 2.ETHICS AND DISSEMINATION: The medical ethical committees of all the participating countries have approved the study protocol. Results of the primary and secondary endpoints will be submitted for publication in peer-reviewed journals.TRIAL REGISTRATION NUMBER: ISRCTN14240288, 20 October 2016. NCT02945566; Pre-results, October 2016.

AB - INTRODUCTION: Total mesorectal excision (TME) is the highly effective standard treatment for rectal cancer but is associated with significant morbidity and may be overtreatment for low-risk cancers. This study is designed to determine the feasibility of international recruitment in a study comparing organ-saving approaches versus standard TME surgery.METHODS AND ANALYSIS: STAR-TREC trial is a multicentre international randomised, three-arm parallel, phase II feasibility study in patients with biopsy-proven adenocarcinoma of the rectum. The trial is coordinated from Birmingham, UK with national hubs in Radboudumc (the Netherlands) and Odense University Hospital Svendborg UMC (Denmark). Patients with rectal cancer, staged by CT and MRI as ≤cT3b (up to 5 mm of extramural spread) N0 M0 can be included. Patients will be randomised to either standard TME surgery (control), organ-saving treatment using long-course concurrent chemoradiation or organ-saving treatment using short-course radiotherapy. For patients treated with an organ-saving strategy, clinical response to (chemo)radiotherapy determines the next treatment step. An active surveillance regime will be performed in the case of a complete clinical regression. In the case of incomplete clinical regression, patients will proceed to local excision using an optimised platform such as transanal endoscopic microsurgery or other transanal techniques (eg, transanal endoscopic operation or transanal minimally invasive surgery). The primary endpoint of this phase II study is to demonstrate sufficient international recruitment in order to sustain a phase III study incorporating pelvic failure as the primary endpoint. Success in phase II is defined as randomisation of at least four cases per month internationally in year 1, rising to at least six cases per month internationally during year 2.ETHICS AND DISSEMINATION: The medical ethical committees of all the participating countries have approved the study protocol. Results of the primary and secondary endpoints will be submitted for publication in peer-reviewed journals.TRIAL REGISTRATION NUMBER: ISRCTN14240288, 20 October 2016. NCT02945566; Pre-results, October 2016.

KW - Adenocarcinoma/pathology

KW - Chemoradiotherapy/methods

KW - Digestive System Surgical Procedures/methods

KW - Europe

KW - Feasibility Studies

KW - Humans

KW - Microsurgery/methods

KW - Organ Sparing Treatments

KW - Rectal Neoplasms/pathology

KW - Rectum/pathology

KW - Regression Analysis

KW - Research Design

KW - Treatment Outcome

KW - Watchful Waiting

U2 - 10.1136/bmjopen-2017-019474

DO - 10.1136/bmjopen-2017-019474

M3 - Journal article

C2 - 29288190

VL - 7

SP - e019474

JO - B M J Open

JF - B M J Open

SN - 2044-6055

IS - 12

ER -